Howmedica Osteonics Corp.: HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900

Hazard

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

Details from the source

Reason for recall: The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments. Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, UK, Venlo. Quantity: 630 units Lot/code info: Part 6210-9-900, UDI-DI: 07613327217902, Lot#: All lots back to 2006.

UPC codes

07613327217902

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.